India’s SEC Recommends Approval of BMS’ Opdivo® for Unresectable or Metastatic Urothelial Carcinoma

India’s Subject Expert Committee (SEC) has recommended the approval of an additional indication for BMS’ Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.  The committee waived the need for a local clinical trial, noting that the proposed indication is approved in US, Europe, United Kingdom, Canada and Brazil.  This combination has also been approved recently in Taiwan (October 2024), where Ono has commercialisation rights.